Actively Recruiting
Phase II Open Label Trial of Belumosudil to Prevent Graft-Versus-Host Disease After Stem Cell Transplant
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-13
46
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the drug belumosudil to standard treatments can help prevent graft-versus-host disease (GVHD) in people with blood cancers who have received a stem cell transplant. This phase II open-label trial aims to assess the safety and effectiveness of belumosudil as a prevention approach for GVHD in patients who are in remission after their transplant. Participants in this study will receive belumosudil, an oral drug that selectively inhibits ROCK2, alongside usual GVHD prevention methods involving immunosuppressive drugs. Eligible patients must have a hematologic malignancy in remission and have undergone a stem cell transplant with specific donor matching and conditioning regimens. The study includes a treatment period where belumosudil is given as maintenance therapy after transplant to reduce GVHD risk. Throughout the study, participants will be monitored for graft-versus-host disease, relapse-free survival, and overall health status for at least one year following their transplant. Assessments include blood tests, liver and kidney function tests, pregnancy tests for women of childbearing potential, and evaluation of engraftment status. Safety and side effects will also be closely observed to understand the impact of belumosudil in this setting.
CONDITIONS
Brief Title
A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older at the time of consent
- Diagnosis of hematologic malignancy in morphologic remission
- Scheduled for reduced-intensity or nonmyeloablative conditioning with CNI-based GVHD prophylaxis plus abatacept or PTCY-based prophylaxis
- Recipients of 7-8/8 HLA-matched related or unrelated donor or related haploidentical donor
- Peripheral blood stem cell graft
- Within 120 days after allogeneic hematopoietic cell transplantation at consent
- Post-transplant: morphologic remission with blasts less than 5%, allowing CRp, CRi, or minimal residual disease
- Achieved engraftment defined as ANC≥500/µL and platelets ≥20000/µL on three consecutive days without recent platelet transfusion
- Between 80 days and 20 days post-transplant infusion
- Karnofsky performance score ≥70%
- ALT and AST ≤3 times upper limit of normal
- Total bilirubin ≤1.5 times upper limit of normal unless benign congenital hyperbilirubinemia
- Glomerular filtration rate ≥30 mL/min/1.73 m2
- Female participants of childbearing potential (≤50 years) must have negative pregnancy tests and agree to use two forms of contraception during and 3 months after treatment
- Male participants with partners of childbearing potential must also agree to use two forms of contraception and avoid sperm donation during and 3 months after treatment
You will not qualify if you...
- Recipients of CD34+ selected or engineered stem cell graft
- Treatment with in vivo T cell depletion such as anti-thymocyte globulin
- Current uncontrolled cardiovascular conditions including arrhythmias, symptomatic heart failure, unstable angina, or recent myocardial infarction within 6 months
- Pulmonary dysfunction with DLCO less than 50% corrected for hemoglobin
- Post-transplant uncontrolled infections including active hepatitis B or C without stable therapy
- Use of investigational agents within 14 days pre-transplant or any time after
- Active acute or chronic GVHD requiring systemic therapy; topical or local treatments allowed
- Active corticosteroid treatment at doses ≥0.25 mg/kg/day for non-GVHD reasons
- Uncontrolled psychosis, active suicidal thoughts, or psychiatric hospitalization within the past year
- Pregnant or breastfeeding females
- Prior treatment with belumosudil
- Known allergy or sensitivity to belumosudil or other ROCK2 inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 1 year after hematopoietic cell transplantation
Participants receive the drug belumosudil to prevent graft-versus-host disease after stem cell transplant.
Trial Site Locations
Total: 8 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
New York University (Data Collection Only)
New York, New York, United States, 10010
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
D
Doris Ponce, MD
G
Gajan Raju, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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